MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CARPENTIER-EDWARDS MITRAL ANNULOPLASTY RING SIZER; SIZER, HEART-VALVE, PROSTHESIS

Model Number 1111

Device Problems Fracture (1260); Contamination /Decontamination Problem (2895)

Patient Problem Injury (2348)

Event Date 11/28/2019

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation.The evaluation is anticipated but has not yet begun.A supplemental report will be submitted upon completion.

Event Description

It was reported that a nurse cut his/her finger at the distal end of the sizer handle where appeared burnt after cleaning the handle before use.The handle was brand new and it went through the cleaning procedure for the first time.Sterilization was not performed yet.The customer commented that ¿there was a brown metal particle approximately 3 mm in length on the distal end of the handle, which also appeared like it was burnt.¿ the sizer handle will be returned for evaluation; however, the particle will not be sent as it was not returned from the hospital.The finger cut did not require any additional treatment.There were no patient complications reported.

Manufacturer Narrative

H10.Additional manufacturer narrative: edwards received additional information through follow up with the healthcare provider.Updated b5.An engineering evaluation was performed and there were no findings from product evaluation and further observations conducted by manufacturing to suggest the brown/burnt discoloration and metal particle were present on the handle.The source of the reported metal particle and a definitive root cause of the reported brown/burnt discoloration could not be conclusively determined.Based on the investigation performed, an edwards and supplier manufacturing defect is not confirmed.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

It was reported that a nurse cut his/her finger at the distal end of the sizer handle where appeared burnt after cleaning the handle before sterilization.The handle was brand new and it went through the cleaning procedure for the first time.Sterilization was not performed yet.The customer commented that ¿there was a brown metal particle approximately 3mm in length on the distal end of the handle, which also appeared like it was burnt.¿ the nurse commented that "the handle was fractured or chipped and the metal particulate was part of it." the sizer handle will be returned for evaluation; however, the particle will not be sent as it was not returned from the hospital.The finger cut did not require any additional treatment.There were no patient complications reported.

Manufacturer Narrative

Per the product evaluation, the customer report of discolored sizer handle was confirmed.Report of brown metal particulate could not be confirmed as particulate was not returned.As received, the distal end of the model 1111 sizer handle appeared discolored with brownish marks.The surfaces of the sizer handle were smooth and without any other visible damages.Sizer handle was able to attach to the returned sizers.Photos provided appeared consistent with lab findings with the exception of the particulate which appeared present near the sizer handle discoloration.As received, discoloration on metal sizer also appeared more faint when compared to discoloration seen in the photos provided.An engineering evaluation will be performed.A supplemental report will be submitted upon completion.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.Corrected data: model # and lot/serial #.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: CARPENTIER-EDWARDS MITRAL ANNULOPLASTY RING SIZER
• Type of Device: SIZER, HEART-VALVE, PROSTHESIS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 9513254
• MDR Text Key: 188676397
• Report Number: 2015691-2019-04897
• Device Sequence Number: 1
• Product Code: DTI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1111
• Device Lot Number: 62196800
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention